Clinical Trial: Computer-Assisted Self-Administration of Ethanol

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Computer-Assisted Self-Administration of Ethanol (CASE) in Humans

Brief Summary:

This study will test the reliability of a procedure for self-administering ethanol (alcohol) intravenously (through a vein), using a computer-assisted method. People ordinarily self-administer alcohol through drinking alcoholic beverages, but blood alcohol levels resulting from drinking vary greatly among individuals. For research on alcohol dependence and treatment, a tool for achieving precise blood levels is needed. In addition to testing this method of alcohol administration, the study will examine self-administration behavior and resulting breath alcohol concentration, the effects of alcohol on the participants, and differences between men and women in alcohol self-administration.

Healthy normal volunteers between 21 and 45 years of age may be eligible for this study. Participants are assigned to one of two study groups. Group 1 undergoes three 7-hour study sessions and group 2 participates in two sessions, each of which includes the following procedures:

  • Breathalyzer and urine tests for alcohol and illicit drug use.
  • Urine pregnancy test for women.
  • Light lunch.
  • Questionnaire about health and recent drinking.

Alcohol infusion: Subjects are seated in a comfortable chair and instructed on how to use a computer to give themselves a short infusion of alcohol through a catheter (plastic tube) that has been inserted into a vein in their the arm. Sensors are placed on their chest to monitor heart beat and their neck to record skin blood flow. At the start of the session, subjects complete questionnaires about any drug effects and urges to drink they may be feeling. They are trained on how to use the computer to administer alcohol and a

Detailed Summary:

Objective: The goal of this project is to characterize the computer-assisted self-administration of ethanol (CASE) paradigm by assessing intravenous (IV) alcohol self-administration behavior and the resulting breath alcohol concentration (BrAC) exposure and pharmacologic responses in healthy non-dependent participants. The study will also evaluate the test-retest reliability of alcohol self-administration and examine the influence of sex and recent drinking history, as well as the effect of acute stress cues on alcohol self-administration.

Study population: Participants will be 21-60 year-old male and female social drinkers and binge drinkers in good health, as determined by medical history, physical exam, ECG and lab tests. Participants with Axis-I psychiatric illness including alcohol or substance dependence will be excluded.

Design: The CASE system utilizes a model-based algorithm based on previously published methods to achieve and maintain pre-determined BrACs using IV alcohol infusions. The CASE system provides flexibility to participants in choosing when to push a button to receive alcohol, as well as flexibility to investigators in controlling the subsequent BrAC exposure. The CASE system allows the investigator to specify and assure the same BrAC increment across all participants, and is set up to prevent the BrAC from exceeding any pre-set upper limit (e.g., 100 mg%).

Following screening, participants will undergo IV ethanol self-administration sessions. Participants will be enrolled in four groups: Group 1 will consist of the first 10 participants who will participate in 3 self-administration sessions (a training session followed by 2 test sessions) to assess the test-retest reliability of alcohol self-administration behavior. Group 2 will consist of 50 participa
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Current Primary Outcome: 1) BrAC Exposure (peak, average, AUC). 2) changes in subjective perceptions, heart-rate, skin blood flow.

Original Primary Outcome: BrAC Exposure (peak, average, AUC). 2) changes in subjective perceptions, heart-rate, skin blood flow.

Current Secondary Outcome: Effect of sex and drinking history on self-administration.

Original Secondary Outcome: Effect of sex and drinking history on self-administration

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: July 10, 2008
Date Started: July 7, 2008
Date Completion: December 31, 2019
Last Updated: May 12, 2017
Last Verified: April 14, 2017